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About OMICS Group
OMICS Group is an amalgamation of Open Access Publications and worldwide international science conferences and events. Established in the year 2007 with the sole aim of making the information on Sciences and technology ‘Open Access’, OMICS Group publishes 500 online open access scholarly journals in all aspects of Science, Engineering, Management and Technology journals. OMICS Group has been instrumental in taking the knowledge on Science & technology to the doorsteps of ordinary men and women. Research Scholars, Students, Libraries, Educational Institutions, Research centers and the industry are main stakeholders that benefitted greatly from this knowledge dissemination. OMICS Group also organizes 500 International conferences annually across the globe, where knowledge transfer takes place through debates, round table discussions, poster presentations, workshops, symposia and exhibitions.
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OMICS International Conferences
OMICS International is a pioneer and leading science event organizer, which publishes around 500 open access journals and conducts over 500 Medical, Clinical, Engineering, Life Sciences, Pharma scientific conferences all over the globe annually with the support of more than 1000 scientific associations and 30,000 editorial board members and 3.5 million followers to its credit.
OMICS Group has organized 500 conferences, workshops and national symposiums across the major cities including San Francisco, Las Vegas, San Antonio, Omaha, Orlando, Raleigh, Santa Clara, Chicago, Philadelphia, Baltimore, United Kingdom, Valencia, Dubai, Beijing, Hyderabad, Bengaluru and Mumbai.
Lean, six sigma and ISO and their applications in clinical trials/research
Pramod Wable, Manager QA GCP_GLP, Daiichi Sankyo Development, UK11 August 2015
4th International Conference and Exhibition on Pharmacovigilance and Clinical Trials
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Lean Six Sigma and Its Applications in Clinical Research
Feel confident about using Lean Six Sigma
Objective
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Let's discuss today!
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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What is Lean?
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
“Continuous removal of the
waste from process,
product and service”
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Five Principles of Lean
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
Waste
PeopleMotion
Transportation Processing
Defects Waiting
Over-productionInventory
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Lean Methodology - How
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
Value Added
Activities
Non-Value Added but Essential Activities
Waste – actions with no value
High Quality &
Defect-Free Process, Product
and Service
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How to improveswimming
Six Sigma -
99.9997%
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
“Simply it is a set of techniques and tools for process improvement”
3.4 defective parts/million
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Design For Six Sigma
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
DEFINE MEASURE ANALYSE IMPROVE CONTROL
Improved Process
Problem and objectives
Problem – what do to improve?
Process and define
factors of improvement
Implement
Maintain the improvements
DMAIC
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Six Sigma Methodology
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Lean Six Sigma
What is it?
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Benefits
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
Cost Reduction
Time Management Cycle Time Reduction
Strategic Planning
Employee, Customer and Stakeholder
Satisfaction
Accelerated Problem Solving
Improved Performance
Enhanced Organizational Capability
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Applications
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
“Industry Independent”Manufacturing
IndustryService Industry
Process Driven Industry
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In Clinical Research
Who is Lean Six Sigma Candidate in Clinical Research?High performing companies
• Benchmark others• Empower employees• Continuously improve
Ultimate Aim = Customer SatisfactionWho is Customer in Clinical Research?• Patients• Doctors • For clinical operations
• Biostatistics, Quality Assurance etc. (internal customer)• Regulatory Agencies such as FDA, MHRA, EMA (customer by proxy)• Insurance companies (intermediate)
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Applications
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
Key – “Focusing on Output Measures” (The ‘X’ factor)
Phase I studies
Clinical Operations
Study Monitoring Activities
Supply Chain
Management
Clinical Quality
Assurance
Project Planning
Clinical Trial Management
Clinical Trial Process
Enhancement
Metrics & BenchmarkingDevelopment
Strategic Development
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Key Potential Difficulties in Application
• Poor understanding • Improper application of statistics/methodology• “Going through the motions”• Lack of time and clarity about project• Resistance to change• Negative perceptions • Lack of effective system of communication
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Case Study - Shopping…!
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
YesNo
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Case Study
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
Ultimate Challenge = Quality with Cost
Source of Table/Information: DOI: 10.1016/j.jala.2005.10.003
De
vel
op
me
nt
Approx. Years
Re
sea
rch
an
d
“Highly Regulated and Expensive Industry”
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Case Study
• Objectivity - reduction of a cycle time and improvement in the process
• Process tested – Paper Case Report Form (CRF) • Sample – 32 patients and 21 CRF pages for each patient• Method – Two methods of CRFs data entry were
comparedA. In-house/organization’s current method of CRFs data entryB. Improved/enhanced CRF data entry process developed by
using Lean Six Sigma• Measures –
• First data entry step• Second data entry step• Isolated time consuming steps affecting process cycle time
and error rate• Time with respect to complete entry of CRFs into database
Elliott Liu - Clinical Research during 2006
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Experimental Observations
A.For In-house/organization’s current method of CRFs data entry:• Labour intensive workflow• Error prone• Multiple QC cycles• Manual query handling• Weeks in data entry and transfer
B. Improved/enhanced CRF data entry process developed by using Lean Six Sigma• Dedicated project team involved• Almost error free within 0.2% acceptance margin of SOP• Less QC activity with more accuracy• Less cycle time
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Outcome and Conclusion
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
Reduction of greater than 70% in cycle time and errors while
CRF Data Entry
Eliminating waste and duplication + Improve and
redesign workflow/processes =
Better and efficient workflow/processes
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The ‘X’ Factor
Focusing on Output Measures is something to look in a rear view mirror.
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Cocktail…!
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Lean Six Sigma WINGS
Be the
Perfection
Lean Six Sigma
Followers Only
Welcome to Heaven
If you QUALIFY; then you will get
a BONUS
I hope this presentation helped you to strengthen your faith on Lean Six Sigma…!
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
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Thank you!
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
Contact –
Pramod Wable
+44 (0) 7872442090
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Useful Reading –
Lean Six Sigma and Its Applications in Clinical Research CONFIDENTIAL
• The Lean Six Sigma Pocket Toolbook: A Quick ReferenceGuide to 70 Tools for Improving Quality and Speed by Michael L. George, John Maxey, David T. Rowlands, Malcolm Upton
• The Lean Six Sigma Black Belt Handbook: Tools and Methods for Process Accelerationby Frank Voehl, H. James Harrington, Chuck Mignosa, Rich Charron
• Velocity: Combining Lean, Six Sigma and the Theory of Constraints to Achieve Breakthrough Performance- A Business Novel by Dee Jacob, Suzan Bergland, Jeff Cox
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Let us meet again..
We welcome you all to our future conferences of OMICS International
5th International Conference & Exhibition on Pharmacovigilance & Clinical Trials
On
September 19 - 21, 2016 at Vienna, Austria http://pharmacovigilance.pharmaceuticalconferences.com/